Comparison of Pipelle endometrial sampling versus Hysteroscopic guided endometrial biopsy in patients with abnormal uterine bleeding -Interventional prospective clinical trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare the diagnostic accuracy of pipelle endometrial sampling versus hysteroscopic guided endometrial biopsy in patient with abnormal uterine bleeding with endometrial pathology which is based on -
研究概览
简要总结
Women with abnormal uterine bleeding presenting at the outpatient department of Obstetrics and Gynaecology who will meet the inclusion criteria will be enrolled in this study .
A detailed examination will be carried out including general physical examination , systemic followed by per speculum and per vaginal examination .All baseline investigations which include complete blood count , coagulation profile ,
thyroid function test, liver function test , renal function test , USG . After taking informed consent and explaining the patient regarding the two methods of the endometrial sampling techniques , patient will be admitted .
After getting a pre anesthesia check up done , and patient will be taken to OT on the scheduled day and sampling will be perfomed prior to anesthesia using pipelle endometrial sampling technique .In case of insufficient sample , proceudre will be repeated once or twice and sample obtained in the container will be labelled as A .
Then under general anesthesia hysteroscopic guided endometrial biopsy will be performed and sample obtained in the container will be labelled as B .
Both the sample with the proper details of the patient will be sent to the pathology lab of AIIMS BATHINDA .
The pathologist will be blind regardiing the sample obtained and sent for histopathological examination .
Patient will be followed up with the histopathological report and two reports obtained from the sampling technique will be further analysed to come to a fruitful conclusion in establishing the diagnostic accuracy of both the methods in abnormal uterine bleeding involving endometrial pathology .
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Women with more than 40 years of age with symptoms suggestive of abnormal uterine bleeding . 2.In pre-menopausal women with endometrial thickness with 7 to 12 millimeters. 3.In post-menopausal women with endometrial thickness with more than 4 millimeters.
- •In post-menopausal women with endometrial thickness less than 4 millimeters endometrial sampling will be done if.
- •a. If repeated bleeding after primary treatment. b. If endometrium shows diffuse /focal increase in echogenicity. c. If endometrium is not adequately visualized on sonography.
排除标准
- •Patient on contraceptives, anticoagulants , thrombolytics or any evidence of blood dyscrasia or coagulation defects, autoimmune illness or chronic illness.
- •Patient with thrombocytopenia ( less than 100000 platelet/mm3 ).
- •3.Patient with active genital infection .
- •4.Patient with focal lesions of cervix or endometrium .
结局指标
主要结局
To compare the diagnostic accuracy of pipelle endometrial sampling versus hysteroscopic guided endometrial biopsy in patient with abnormal uterine bleeding with endometrial pathology which is based on -
时间窗: It will be analysed based on the histopathological report obtained by the two screening techniques which will be available in 1 week
1. Histopathological report obtained by the two sampling techniques
时间窗: It will be analysed based on the histopathological report obtained by the two screening techniques which will be available in 1 week
次要结局
- To compare the pipelle endometrial sampling versus hysteroscopic guided endometrial biopsy as two screening modalities in terms of
研究者
Dr Neelima Chelluru
All India Institute of Medical Sciences , Bathinda